Lenvatinib plus hepatic arterial infusion of modified FOLFOX regime in patients with advanced hepatocellular carcinoma.

Abstract

e16603 Background: Recently, Sorafenib plus hepatic arterial infusion chemotherapy (HAIC) of modified FOLFOX regime has shown promising results for patients with advanced hepatocellular carcinoma. Lenvatinib is also the first-line treatment for advanced hepatocellular carcinoma, it has shown the better objective response rate (ORR) and longer progression free survival (PFS) than sorafenib. This retrospective study evaluated the combination of lenvatinib plus HAIC of modified FOLFOX regime in patients with advanced hepatocellular carcinoma. Methods: This study retrospectively enrolled and analyzed 24 patients from Nov 2018 to May 2019 from Guangdong provincial people’s hospital. Patients with advanced hepatocellular carcinoma were treated with 8 mg(≤60kg) or 12mg( > 60kg) lenvatinib once daily plus HAIC of modified FOLFOX regime (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, fluorouracil bolus 400 mg/m2 on day 1, and fluorouracil infusion 2400 mg/m2 for 46 hours, every 3 weeks). Best response according to the RECIST 1.1 and mRECIST criteria. PFS, overall survival (OS) and treatment-related adverse events(TRAE) were also evaluated. Results: 24 patients(median age: 49.2 years) underwent a total of 91 cycles of HAIC therapy (mean: 3.79; range: 2-8). 22 (91.7%) patients had cirrhosis caused by HBV infection.17(70.8%) patients were diagnosed with vascular invasion and 7 (29.2%) were both vascular invasion and extrahepatic spread. 20 (83.3%) patients were classified as Child-pugh A class and 4 (16.7%) patients were Child-pugh B class. The ORR were 58.3% (RECIST) and 66.7% (mRECIST), the disease control rate (DCR) was 79.2% (RECIST/mRECIST). With a median follow-up period of 11.3 months, the median PFS was 8.1 months. 6-, 9-, and 12-months OS rates were 91.7, 83.3%, and 75%, respectively. TRAE occurred in 20 of 24 patients (83.3%), most common TRAE were hypertension (41.7%) and hand-foot skin reaction(25%). No grade 3/4 TRAE was observed. Conclusions: Lenvatinib plus HAIC of modified FOLFOX regime was well tolerated and had shown promising ORR, PFS and 6-, 9-, and 12-months OS rates in advanced hepatocellular carcinoma. A prospective large-scale trial is needed to justify these results. [Table: see text]